Seagen Inc. - SGEN STOCK NEWS

Seagen Inc. (NASDAQ: SGEN) will announce its fourth quarter and full year 2021 financial results on February 9, 2022, after U.S. market close. The management will hold a conference call at 4:30 p.m. ET to discuss the results and provide business updates. Investors can access the call at 844-763-8274 (U.S.) or +1 412-717-9224 (international) using conference ID 10163004. A webcast will also be available on their website.

Seagen Inc. (Nasdaq: SGEN) will present virtually at the 40th Annual J.P. Morgan Healthcare Conference on January 10, 2022, at 3:00 p.m. Eastern Time. The presentation will be accessible via a live webcast, with a replay available in the investor section of Seagen’s website.

Seagen is a global biotechnology firm focused on discovering, developing, and commercializing transformative cancer therapies, with its headquarters in Seattle, Washington, and additional locations in California, Canada, Switzerland, and the European Union.

Astellas Pharma and Seagen announced that the European Medicines Agency (EMA) has positively evaluated PADCEV (enfortumab vedotin) for advanced urothelial cancer patients who have undergone platinum-based chemotherapy and PD-1/L1 inhibitors. This marks a significant step as it could be the first antibody-drug conjugate approved in the EU for this condition. The recommendation is based on the Phase 3 EV-301 trial data, highlighting overall survival improvements. The final decision by the European Commission is awaited. Bladder cancer, the most common type of bladder cancer, sees high incidence and mortality rates in Europe.

Astellas Pharma and Seagen announced a positive opinion from the European Medicines Agency's CHMP, recommending approval for PADCEV™ (enfortumab vedotin) as a treatment for adult patients with advanced urothelial cancer previously treated with chemotherapy and a PD-1/L1 inhibitor. This marks a significant step toward making PADCEV the first authorized ADC for advanced urothelial cancer in the EU, addressing a crucial treatment gap. The CHMP's recommendation is based on data from the phase 3 EV-301 trial, which showed improved overall survival compared to chemotherapy.

Seagen Inc. (Nasdaq:SGEN) announced promising results from a phase 2 clinical trial involving ADCETRIS in combination with nivolumab, doxorubicin, and dacarbazine for treating advanced classical Hodgkin lymphoma. The trial demonstrated a remarkable complete response rate of 88% and an overall response rate of 93% among 56 patients. The treatment was well-tolerated, with few adverse events reported. Seagen anticipates further results from this trial to enhance ADCETRIS's efficacy in treating Hodgkin lymphoma.

Seagen Inc. announced new data from the HER2CLIMB trial, showing that patients with HER2-positive metastatic breast cancer experienced a significant overall survival (OS) benefit of 9.1 months when treated with TUKYSA combined with trastuzumab and capecitabine, compared to the latter two drugs alone (21.6 months vs. 12.5 months). These findings, presented at the San Antonio Breast Cancer Symposium, also demonstrated improved progression-free survival in the central nervous system for patients with stable and active brain metastases.

Seagen has announced significant data regarding TUKYSA (tucatinib) at the upcoming San Antonio Breast Cancer Symposium. The findings from the pivotal HER2CLIMB trial show that TUKYSA, in combination with trastuzumab and capecitabine, provides clinically meaningful benefits for patients with HER2-positive breast cancer who have brain metastases, demonstrating a median overall survival of 11.9 months.

This data underlines the importance of TUKYSA as a systemic therapy for challenging leptomeningeal metastases, improving treatment prospects where prognosis is typically poor.

Seagen announced the advancement of two new antibody-drug conjugate (ADC) programs, SGN-PDL1V and SGN-B7H4V, into Phase 1 studies, boosting its pipeline to 10 ADCs. These ADCs target immune checkpoints with preclinical data showing promising antitumor activity. SGN-PDL1V targets PD-(L)1, exhibiting strong activity in xenograft models, while SGN-B7H4V targets B7-H4, showing effectiveness in various solid tumors. Both ADCs are set for first-in-human studies in 2022, as presented at the Society for Immunotherapy of Cancer Annual Meeting.

Seagen Inc. (SGEN) announced the presentation of new data for ADCETRIS (brentuximab vedotin) at the upcoming American Society of Hematology Annual Meeting from December 11-14, 2021. This includes five oral presentations and updates on its efficacy and safety in treating various lymphomas. Notably, initial results from the SEA-BCMA program, targeting relapsed/refractory multiple myeloma, will also be shared. ADCETRIS is approved in over 75 countries for specific lymphoma types, emphasizing its significance in oncology.